Senior Statistical Programmer

작업 내용

Job Title

Senior Statistical Programmer

Job Location: Anywhere in India (Full time home based role)

Job Overview

The Senior Statistical Programmer is responsible for all aspects related to programming activities for the data preparation and analysis of clinical data. Duties include creating all datasets, tables, listings and figures according to the project specifications as well as coordinating quality control efforts and implementing all programming required for study/project completion.

Job Duties

And Responsibilities

• Development and documentation of programs used in the production of computer generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data, e.g. answers to requests from health authorities, individual sponsors requests, scientific papers and conferences, etc. in line with existing regulatory guidelines, industry standards and standard operating procedures issued by Clinipace and/or clients as appropriate.
• Generation and review of dataset specifications
• Development and documentation of programs used to generate datasets
• Development and documentation of programs used to generate listings, tables and graphs
• Program validation including generation of validation documentation
• Data preparation and documentation according to CDISC data standards
• Design of integrated databases and development of mapping specifications for integrated datasets
• Preparation of electronic submission of clinical data
• Intense and cross functional interaction with other members of the project team
• Perform all programming work in accordance with the Clinipace SOPs
• Providing internal consultancy in various review activities like database design, data validation rules, analysis plans, table shells etc.
• Interaction with clients
• Design, development, documentation and validation of tools and macros to continuously improve quality and efficiency of processes applied
• Writing of User Manuals
• Training of group members on new processes, programs etc. as appropriate
• Initial Training on existing processes, programs etc. for new group members
• Attending and representing the company at business conferences
• Participation in industry working groups
• Perform the role of the lead statistical programmer on projects where required. The responsibilities of the lead programmer include, but are not limited to:
• Monitoring resource needs, feeding back to programming management on the resource requirements of the study
• Monitoring of timelines, ensuring that the internal and external deadlines are met
• Implementation of study specific efficiencies (e.g. study macros), including training of the programming team on their usage
• Ensuring that the project teams are working in accordance with study specific requirements, as well as within the Clinipace SOPs, including ensuring that documentation and trackers are kept up to date
• Coordination with other departments, such as biostatistics, data management and project management
• Monitoring of study proposal assumptions and budgets, as well as flagging to project management if tasks outside the scope of the budget assumptions are identified
  

Supervisory Responsibilities

No supervisory responsibilities

Job Requirements

• Education
• BSc, MSc or equivalent experience in information technology, mathematics, statistics or life sciences Experience
• Minimum of 5+ years’ experience in processing and analyzing clinical trial data or demonstrated aptitude for statistical programming work
• Minimum of 5 years’ practical experience in the use of SAS with respect to all aspects of software development and validation
• Skills/Competencies
• Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities)
• Fluency in English
• Expert knowledge in SAS
• Knowledge of relevant regulatory requirements
• Knowledge of medical terminology and conduct and analysis of clinical trials
• Knowledge of different indications of clinical trials
• Knowledge of industry data standards (e.g. CDISC SDTM and ADaM)
  
The company will not accept unsolicited resumes from third party vendors.